Zactima: Withdrawal of the marketing authorisation application

Table of contents

Overview

On 27 October 2009, AstraZeneca officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zactima, for use in combination with chemotherapy, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously received anticancer treatment.

Zactima is a medicine that contains the active substance vandetanib. It was to be available as tablets.

Zactima was expected to be used in combination with chemotherapy (medicines to treat cancer) to treat patients with NSCLC who have previously received anticancer treatment. It was to be used in patients whose cancer is advanced or metastatic (has spread to other parts of the body).

The active substance in Zactima, vandetanib, is a tyrosine kinase inhibitor. This means that it blocks specific enzymes known as tyrosine kinases. Vandetanib was thought to block the activity of a tyrosine kinase called VEGF receptor, an enzyme that makes blood vessels grow. By attaching to VEGF receptor, Zactima was expected to stop the cancer cells from developing their own blood supply, helping to slow down the growth of the cancer. Vandetanib was also expected to work by blocking another enzyme called EGFR, which is involved in the growth and spread of cancer cells.

The effects of Zactima were first tested in experimental models before being studied in humans. The company presented results of two main studies in 1,927 patients with NSCLC that was advanced or had spread to other parts of the body. The patients had previously received anticancer treatment.

Patients were given docetaxel or pemetrexed (other anticancer medicines used in NSCLC) together with either Zactima or placebo (a dummy treatment). The main measure of effectiveness was how long the patients lived without their disease getting worse.

The application was at day 96 when the company withdrew. The CHMP was evaluating the initial documentation provided by the company.

The CHMP normally takes up to 210 days to evaluate a new application. Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company. Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180. Following the CHMP's opinion, it usually takes around two months for the European Commission to issue a decision on this opinion.

The CHMP was evaluating the initial documentation provided by the company and had not yet made any recommendations.

The letter from the company notifying the CHMP of the withdrawal of the application is available under the tab 'All documents'.

The company informed the CHMP that ongoing clinical trials in NSCLC and other conditions will continue. Zactima will continue to be made available to patients in these trials.

Related information on withdrawals

A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter (withdrawal letter Doc. type, leave the 'Author' in properties blank).

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').